Sumitomo Pharma America, Inc.
We are united in our mission to deliver patient-needed therapies sooner.
Manager, R&D Applications
Location
United States
Posted
121 days ago
Salary
$127.4K - $159.3K / year
Bachelor Degree7 yrs expEnglish
Job Description
• Serve as the primary liaison between R&D Clinical Operations team and IT
• Responsible for the delivery and support of technology solutions that align with business needs and operational demands
• Partner with Clinical business stakeholders to co-create technology plans which support their business objectives and operational demands
• Continuously assess current systems environment and identify changes (process and/or system) that enhance effectiveness
• Assist in the evaluation of new technology systems and/or service providers
• Oversee end-to-end management of IT projects—including planning, design, and implementation—ensuring projects are delivered on time, within scope, and with measurable business impact
• Work with a team of managed service providers supporting the lines of business technology needs including project delivery, solution design, enhancement requests and support services
• Accountable for managing clinical application systems through their full lifecycle, from implementation to ongoing optimization
• Lead and initiate troubleshooting quality and/or functionality issues associated with technology systems in scope
• Develop and maintain comprehensive project documentation, ensuring centralized storage and accessibility for knowledge management
• Manage and prioritize system enhancements and fixes in collaboration with business stakeholders
• Provide regular project status reports, manage issues proactively, and adjust schedules as needed while maintaining alignment with the overall program plan
• Responsible for timely execution of all GxP system commitments and compliance activities (Backup recovery, Disaster Recovery testing etc.)
• Collaborate with cross-functional IT teams to ensure seamless delivery of services, efficient communication, and shared accountability for outcomes
• Establish clear performance metrics and service level agreements (SLAs) to monitor IT service delivery, project outcomes, and stakeholder satisfaction
• Stay informed of emerging industry trends, best practices, and regulatory changes to proactively recommend technologies and process adaptations that empower the company during phases of rapid expansion
• Serve as the IT subject matter expert for application upgrades, integrations, and system enhancements across supported business areas
Job Requirements
- 7+ years of progressively increasing experience managing clinical applications in a Pharma/Biotech company
- Strong understanding of building and operating a technology support function
- Proficient in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment
- BS/BA degree in a related discipline is required.
- Training or equivalent experience in IT or business management is beneficial but not required
- 7+ years of experience in life sciences with a focus on IT system delivery
- 5+ years of experience in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment
- Experience in Program & Project Management, including the Software Development Lifecycle and Computer Systems Validation process
Benefits
- Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases
- short incentive plan participation
- eligibility for our 401(k) plan
- medical, dental, vision, life and disability insurances
- robust time-off policy which includes flexible paid time off
- 11 paid holidays
- additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
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